HepHospital: A Pilot Trial of a Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease

Not Applicable

Recruiting

• Conditions: Cirrhosis; Liver Disease Chronic; End Stage Liver DIsease; Liver Cirrhosis

• Registration Number: NCT05205954
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This research study is evaluating a program that entails a healthcare at home intervention for people with advanced liver disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-25
• Status Verified: 2025-07
• Study Start: 2025-07-21
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Adult patients ≥ 18 years old with diagnosis of cirrhosis based on histology, radiology, and/or elastography presenting to the emergency department or inpatient general medicine service

2. Patients must have one of the following:

   1. Ascites (requiring diuretics or serial large volume paracenteses)
   2. Hepatic hydrothorax (requiring diuretics)
   3. Hepatic encephalopathy (requiring medications)

Exclusion Criteria

All existing MGB home hospital criteria apply, with the following taking precedent for this specific condition

1. History of solid organ transplantation
2. On hemodialysis
3. MELD score > 20
4. Score <10 on Simplified Animal Naming Test (S-ANT1)
5. Current admission for hemodynamically significant GI bleeding or alcohol withdrawal
6. Require routine administration of controlled substances
7. Those deemed ineligible based on the MGH Home Hospital, inpatient medicine or hepatology clinician evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Escalation Rate	18 months	The intervention will be deemed feasible if less than 20% of enrolled patients have escalation of care back to the inpatient (brick-and-mortar) hospital

Secondary Outcome Measures

Name	Time	Method
Patient Experience	Up to 90 days	To assess patient experience scores (Picker Patient Experience Questionnaire, Global satisfaction questionnaire) at discharge from HepHospital
Adverse Event Reporting	Up to 90 days	We will assess rates of adverse events (acute kidney injury, falls, delirium, deep vein thrombosis/pulmonary embolism, escalation of care back to an inpatient hospital setting for at least 1 overnight stay, and death) for patient enrolled in HepHospital
Acceptability	18 months	Qualitative acceptability ratings from patients, caregivers, and clinicians obtained via exit individual interviews regarding acceptability (i.e. usefulness, effectiveness, and relevance of the intervention) from patients, family caregivers, and clinicians.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States